Global Product Monitoring Vigilance Report Writer
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Job Description
Global Product Monitoring Vigilance Report Writer maintaining quality assurance methodologies in the medical device industry. Focusing on post-market vigilance and compliance reporting with collaboration across various teams.
Responsibilities:
- Responsible for the assessment, follow-up, coding, and vigilance activities for complaints globally.
- Author, peer review, and approve vigilance reports to ensure on time submissions to the appropriate regulatory authorities.
- Support management in day-to-day operations in a fast-paced work environment; Support proper coding of complaints and reportable events.
- Collaborate with engineering, complaint investigation laboratory, medical and other internal staff to review events, coding, and investigation results to support regulatory reporting compliance.
- Contribute to departmental non-conformances escalated into CAPA System.
- Serve as a subject matter expert for post-market and complaint handling regulatory questions and inquiries.
- Support internal and external audits and inspections.
- Assist with special projects, as assigned, with minimal supervision.
- Perform other duties as required.
Requirements:
- Bachelor’s degree or appropriate combination of relevant education and experience.
- Demonstrated experience in medical device complaint triage and vigilance reporting or clinical experience in diabetes disease management or diabetes device support.
- Strong proficiency in common computer applications such as Microsoft Office (Excel, Word, Outlook) and complaint database applications.
- Effective verbal and written communication skills.
- Ability to generate, verify, and maintain accurate records.
- Must have analytical skills, be detail oriented, and have good interpersonal skills.
- Demonstrated ability to influence without authority.
- Ability to organize, judge priorities, and escalate when applicable.
- Strong emphasis and understanding of a formalized medical device Quality Management System.
- Direct experience of writing and filing global vigilance reports within the medical device industry.
- Working knowledge/experience with global, multi-country vigilance reporting requirements for medical devices and demonstrated knowledge of country-specific differences and requirements.
- Experience in dealing directly with regulatory bodies is highly desired.
- BSN with diabetes experience, Registered or Licensed Dietician or Diabetic Educator, preferred.
Benefits:
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
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